Chrysalis Intelligence · Sponsors · Innovative Health, LLC

Innovative Health, LLC

Scottsdale, AZ, US · 19 510(k) clearances

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Total clearances
19
2020-01-24 → 2026-01-07
Last 12 months
1
Product codes
9
Most recent
2026-01-07
Name variants in FDA filings: Innovative Health, LLC / Innovative Health
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NLH Catheter, Recording, Electrode, Reprocessed Class II Cardiovascular 5 2024-06-07
PNE Reprocessed Catheter Introducer Class II Cardiovascular 4 2026-01-07
QLZ — — — 2 2023-04-04
OWQ Reprocessed Intravascular Ultrasound Catheter Class II Cardiovascular 2 2022-05-25
NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed Class II Cardiovascular 2 2021-12-20
NLI Catheter, Angiography, Reprocessed Class II Cardiovascular 1 2024-07-01
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Class II Cardiovascular 1 2021-03-05
MTD Catheter, Intracardiac Mapping, High-Density Array Class II Cardiovascular 1 2020-09-03
NMK Trocar, Reprocessed Class II Cardiovascular 1 2020-07-22
Filings

All 510(k) clearances (19)

Date K-number Device Code Class Specialty
2026-01-07 K250305 Reprocessed Agilis NxT Steerable Introducer PNE Class II Cardiovascular
2024-07-01 K231015 Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters NLI Class II Cardiovascular
2024-06-07 K233825 Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter NLH Class II Cardiovascular
2024-04-04 K232037 Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath PNE Class II Cardiovascular
2023-08-07 K230376 Reprocessed Agilis NxT Steerable Introducer PNE Class II Cardiovascular
2023-04-04 K213584 Reprocessed NRG Transseptal Needle QLZ — —
2022-08-06 K221854 Reprocesses Umbilical Cable NLH Class II Cardiovascular
2022-05-25 K210655 Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter OWQ Class II Cardiovascular
2022-03-10 K212165 Reprocessed Carto Vizigo Bi-Directional Guiding Sheath PNE Class II Cardiovascular
2021-12-20 K212776 Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled NLG Class II Cardiovascular
2021-11-18 K211662 Reprocessed IntellaMap Orion High Resolution Mapping Catheter NLG Class II Cardiovascular
2021-09-15 K211276 Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters NLH Class II Cardiovascular
2021-05-04 K203655 Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) NLH Class II Cardiovascular
2021-03-05 K203261 Reprocessed Inquiry Steerable Diagnostic EP Catheter DRF Class II Cardiovascular
2020-11-20 K202042 Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter OWQ Class II Cardiovascular
2020-09-03 K200212 Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled MTD Class II Cardiovascular
2020-07-30 K200060 Reprocessed NRG Transseptal Needle QLZ — —
2020-07-22 K192998 Reprocessed BRK Transseptal Needle NMK Class II Cardiovascular
2020-01-24 K193263 Reprocessed Achieve Catheter Connecting Cable NLH Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence